IAM Lynn Webster M.D., VP of Scientific Affairs at PRA Health Sciences, and I’m conducting clinical studies in people who admit to using opioids recreationally. We’re trying to develop medications that are harder to abuse and to prevent all uninte...

What do you think about cannabis research as a potential alternative for opiates?

This is something that I've been recommending for some time. I've recommended the DEA reschedule cannabis so that research can be conducted more easily. It may well be a good substitute for opioids. BUT we need the research.

Edit: Here's an op-ed I wrote on the subject.

Is there any way you can see the end to the stalemate of "cannabis is schedule 1 so it's really hard to research, and we won't make it schedule 2 until there is more research"?

Apart from just every state ignoring federal law one by one?

It is a Catch-22. The research has not been done because we can't do the research. Only the government can make sense of that.

I think when nearly every state in the Union legalizes marijuana, Congress will force the DEA to reschedule cannabis. I actually have an op-ed coming out in Pain Medicine News in its November issue on this topic.

Why is there no government official even willing to sit down and negotiate some type of help for the chronic pain patient? Aren't there ways we could help the chronic pain patients while still helping the government's war against heroin?

The squeaky wheel gets the grease. People in pain just don't get heard. I don't believe people are intentionally trying to hurt those in pain, but ignoring them tends to be the default.

How do you differentiate those who are rationalizing their need for opioids based on pain(as addiction is very good at causing) or those who actually need them?

That's a challenge for all physicians. It is not easy to sort that out. Over time, we should see an improvement in function and/or quality of life; if not, then the opioids may not be providing any benefit.

Hi Dr. Webster, thanks for your time. I'm not a recreational user, I am a chronic pain sufferer that's tried anything, and everything, that's been offered aside from an implantable pump. (I have to draw the line somewhere.)

As it is, I need to go to a pain clinic for narcotics, and every 30 days for a paper script. (CA) This means driving 45 minutes, each way, with a spine and thoracic cage that hurts with bed rest, let alone all that axial loading.

Once you come up with a safer alternative, will it still manage pain? Or, is it like the additives that prevent addicts from liquefying or snorting the substance? Or, does it eliminate the euphoria some people feel?

As a former paramedic, and now chronic back pain sufferer, it's already nearly impossible to manage my pain so I am looking for alternatives.

I understand. I took care of thousands of people like you. I recognize how much you struggle with just living day by day. I want you to understand that there are non-addictive, non-euphorigenic drugs in development that are far better than anything we have today.

Hopefully they can be brought to the market soon and you can get some relief.

Hello, My question: why does it HAVE to always be an alternative to opioid based medications? Why must we stop the use of safe(when used appropriately) plant derived pain relief medications that work extremely well and have for a thousand years, just because some people abuse them until they die. Why is the addicts life suddenly more important than the intractable pain patients?

This all comes down to forced morality IMO. This might sound insensitive but we pain patients are angry so here it goes.

Decriminalize, regulate, educate and tax. If your not smart enough to figure out that in no way should you take 98 Vicodines a day, well thats your problem. stop forcing morals down other people's throats.

We need to end this war on drugs and it is no ones business what someone else puts in their body. What are your opinions on decriminalization of all drugs? Thank you for all you do for our community.

There is considerable confusion about the opioid problem in America. Most people are not harmed when prescribed an opioid, but there are a large number of people who are harmed. This is why we're trying to find safer opioid formulations that are less abusive but still can be available for the people that need them.

People in pain deserve humane treatment and often opioids may be appropriate.

Dr. Webster, when do you foresee the government doing anything to help chronic pain patients who are now going from functioning to bedbound due to discontinuance of their pain meds?

In order for policymakers to help people in pain, there will need to be a movement comparable to the level of activity put forth by AIDS patients and advocates in the 80s. We have to have a groundswell of voices demanding that patients are treated with humanity.

That's kind of a big request of people in excruciating pain, isn't it?

Yes it is. That's why we need to find surrogates to help advocate for people in pain (and why I'm doing this AMA today). I'm trying to support the needs of people in pain.

To be fair I have watched my MIL go the opposite direction. She was functional and able until she got addicted to opiates. They now have her on fentanyl patches and barely gets out of the house but for appointments. She complains about pain constantly from a damaged nerve that left no physical impairment and varies greatly day to day. She is severely addicted and it seems to cause her a great deal of pain.

On the other hand I also have a severely herniated disk in the same area, and worked as well as went to school for 2+ years before surgery. But without taking opiates at all. I fully recovered, where as she allegedly didn't even though her disk was herniated for less than a year.

There is up to a ten-fold difference in response to the same level of pain stimulus from one individual to another. It is unfair to judge somebody else's response to pain based upon your response. I'm glad you are doing well.

How can we get the CDC and our elected representatives to separate opioid pain medication deaths from heroin deaths so we can get a better picture of the problems with prescribed opioids? I have no idea how dangerous my medication is, as prescribed, when they're grouped together in every study.

You have identified a MAJOR challenge. The CDC can only report what they receive from coroners and medical examiners. We need to have entirely different death reporting mechanisms to have better data.

I really think part of the problem is they cannot easily differentiate in a blood test. Fentanyl breaks down into morphine and down the opiate line. All they can really tell is that it was an opioid OD. There are always a slew of different forms in the system.

Actually, the CDC cannot usually determine cause of death. They can report if an opioid is present, contributes, or probably caused a death. In most instances, deaths are associated with multiple drugs. It's also true that heroin metabolizes to morphine. In June 2016, the CDC revised the unintentional overdose deaths downward by almost 4,000 annual deaths to take into account the probably involvement of heroin–rather than morphine–in the overdose deaths. Yet even one death is tragic.

Why do you hate fun?

No I'm totally kidding, my SO was addicted to opiates for several years, and constantly struggles with desire to relapse. I just have a morbid sense of humor.

My real questions are:

1. Would a non-addictive pain medication avoid any of the negative side effects of opiates? I can barely tolerate most pain medications in any effective dosage because they make me nauseous and itchy.

2. Would any of the options you are researching be helpful for weaning opiate addicts off the drugs safely, like suboxone or methadone (which, admittedly, have limited success)?

3. In your opinion, how can we limit illegal access to opiates without denying them to patients who really need them?

1. All medications have side effects–whether addictive or non-addictive–unique to that chemical and individual. People and their physicians have to evaluate whether the benefit outweighs the risk.

2. Yes. We have several non-opioid treatments for people who have opioid addictions that we think are better than the current options.

3. This is very difficult because there is so much profit and demand. Most of the harm produced by opioids occurs in those for whom opioids aren't currently prescribed. Most people prescribed opioids take them responsibly and are not harmed by them. Unfortunately, there is a subset of the population who are harmed.

Again, this is why we need to find alternatives to opioids.

Thank you! I think the work you're doing is incredible. I would love to live in a world where non-opiate painkillers are an option - it would benefit so many people.

Oh, I have one more question. Do you expect any pushback from pharmaceutical companies in the future?

Thank you. My area of work is very interesting and rewarding when we can make a difference in other people's lives. I'm not sure what you mean by pushback, but the pharmaceutical companies are profit-drive and react to incentives. When there's a potential for profit, they will be there.

Thank you. My area of work is very interesting and rewarding when we can make a difference in other people's lives. I'm not sure what you mean by pushback, but the pharmaceutical companies are profit-drive and react to incentives. When there's a potential for profit, they will be there.

I suppose what I meant was "Do you think there will be any resistance to manufacturing/promoting the use of alternative medications, when opiates are so popular, and the addictive nature of them keeps demand fairly steady?"

The demand for opioids can be met with illegal supplies. There won't be any resistance from pharmaceutical companies if alternative medications can be profitable. Keep in mind insurance companies also play a major role in what drugs are profitable.

The demand for opioids can be met with illegal supplies.

In light of that product substitution risk, are you at all concerned that ADFs might lead opioid-dependent populations towards black market opioids? (eg counterfeit non-ADF formulations, heroin, etc)

I'm always concerned that someone might use an illegal supply of opioids that could be laced with lethal substitutes. There are several reasons why people might move to illicit drug supplies.

One would be because they are no longer able to access medication to treat their pain. Another reason is that they were using the medicine for the wrong purpose and actually had the disease of addiction. There are other reasons as well, but regardless I am concerned that our introduction of safer treatment options might lead some individuals to seek more dangerous substitutes. That doesn't mean we shouldn't try to make the formulations safer.

How did you go from clinical practice to working for a pharmaceutical? I am a second year internal medicine resident who is strongly considering a career in conducting clinical trials. Were you sure you would like it?

I don't work for pharmaceutical companies. Our clinical research organization (CRO) contracts with pharmaceutical companies to conduct the trials.

I spent most of my career in clinical practice, but while always having a hand in clinical research. Now, I am full time in clinical research which is very rewarding!

Here's my question: what is your take on the pharmaceutical lobby bankrolling the anti legalization efforts of medicinal cannabis and do you think cannabis is a safer alternative than methadone/suboxone for helping people stave off opioid/opiate addiction?

I'm not aware of the opposition by pharmaceutical companies that you reference. Medical cannabis is usually not an alternative to methadone or suboxone but clearly cannabis is safer than methadone or suboxone. As you probably know, there have been no reported overdose deaths from cannabis. We do not know the benefits of cannabis–but the harm is substantially less than methadone or suboxone.

Thank you so much for your work. Do you have any suggestions for conversations with doctors who are decreasing/ending our opioid prescriptions? My doctor of 12 years is leaving her practice, and now I have to start all over again. I have an invisible illness - chronic daily migraine. I have tried many, many things, including a nerve stimulator surgery, where I was disabled for months due to a MRSA infection, and the darn thing had to be removed. My opioid dosage has not increased in years. Anyway, just looking for some concrete ideas to get my point across to the doctor that a very small amount of opioids continues to help me function. BTW - best of luck with your research. I think we can all agree that making opioids irrelevant in the future is the goal.

It is extraordinarily sad for me to see the way people in pain are treated. Sounds like you are one of them. My recommendation is to be very transparent with your physician. Ask that he or she spend time to understand your needs and then you have to reciprocate their respect and fear of the DEA.

Do you foresee these drugs becoming available over the counter? Since there would be no risk of addiction or overdose.

Addiction and overdose are not the only risks associated with medications. Some of these new medications may be available over-the-counter, while others should not be available over the counter because of the risks associated with them beyond addiction or overdose.

Could you potentially elaborate on your statement of addiction and overdose not being the "only risks associated with these medications"? What other risks are there at large thru the majority of these trialed medications?

There are a number of side effects that can occur with opioids -- these include depression, cognitive impairment, constipation, loss of libido, and increased pain.

What are your views on Kratom (mitragyna speciosa) as an alternative to opioid painkillers and as a tool to help opioid addicts wean off of their substance? And how do you feel about the DEA's recent decision to place the active compounds of the plant on Schedule I?

We need more science to know what the risks and potential benefits are for kratom. However, I believe we need to do the research and it should not be Schedule I. This limits our ability to determine the safety and potential efficacy of kratom in different disease states.

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Belbuca and Bunavail are buprenorphine formulations. Buprenorphine is an opioid. Belbuca is for chronic pain and Bunavail is for opioid addiction. I think both can be effective in a subset of the population. They appear to have less risk than other types of opioids.

How can we separate the drug interactions in the brain between pain and addiction?

Feel free to go all geek on me!

I'm not sure I understand your question. Most drugs are not associated with addiction. There are medications that work in the brain that both treat pain and cause addiction. This is why we need to find safer, more effective therapies.

Why is it we haven't seen such a major push of guidelines with regards to other types of controlled substances such as stimulants/adhd medications? I've heard some chatter about more restrictions for some people on them but for the most part there aren't expensive urine screens, regular pill counts (if any at all), or the requirement of needing a visit every 28-30 days for a new script. I'm curious about the focus on opioids only when there are many other types of meds that are able to be "abused".

You're absolutely correct. There are many drugs that are commonly abused. The reason why there is a focus on opioids is just because of the number of people who have overdosed and died.

How do you feel about the impending ban on Kratom, a non narcotic substance that has helped many opiate addicts, one being myself, wean off of opiates?

Kratom is a potential therapy, but it needs to be researched. The DEA should not schedule it in a way that makes it more difficult for us to conduct the appropriate research.

Hi,

You do acknowledge that opioids have more uses than in pain management right? For example, Tramadol, a partial opiate antagonist also is a serotonin releasing agent and has been used in treatment for some conditions such as OCD (non pain related).

The reason I bring this up is because I feel this attack on opioids and blaming the doctor will ruin it for the rest who benefit from it that don't use it for pain.

Opioids have been used for more than pain management, however, the FDA indication limits opioid prescribing. Physicians can prescribe off-label and if there's evidence to support the off-label use, then it's possible opioids can be prescribed for other indications.

Have you had any run-ins with big pharma, presumably due to them not liking what you're doing?

I'm not sure what you mean by run-ins. I work with pharma on a daily basis to find therapies and medicines that will improve the qualities of lives. Without pharma's success, we would not have the successful treatments for cancer and other therapies that have improved our qualities of life.

What are your thoughts/opinions on right to die? Are you familiar with the "death bag"? If so, do you think it's better or worse than, say, intentionally overdosing on Fentanyl.

I don't believe my opinion is important. I do realize that some people intentionally overdose to escape pain, but I believe this is a very personal issue that each individual has to process for themselves.

Could you please just invent one that doesn't make me hallucinate? I'm going to need surgery sooner or later in life and as of right now I'm fucked.

I assume you are asking for a safer and more effective medication. There are many companies working to develop those products now. Hopefully they'll be available to you soon.

Hey i'm a former opiate junkie, wasted away my 20's.
I've been clean for 2 years, but rely on my CBD oil for sleep, and also THC oil and vape flower for daily anxiety/depression. It has been wonderful!!
So my question, can CBD lower you THC level in your body?? I've read this and just wondering if it's rumors or what?? Could you expand a little. Thanks for doing this AMA <3

I've not heard that before, but it's not something that I would predict.

I believe CBD could be the next big thing for pain managment, if big pharma ever lets it truly see the light of day (which would mean they would have their sticky hands in there). What your thoughts??

It appears CBD is very effective for certain types of seizures. We do not have good data on its effectiveness for treatment of pain. The barrier to researching and producing CBD products are mostly regulatory and not by pharma.

Do you think pharmaceutical companies would jump at the chance to research CBD for pain management if those regulatory constraints were lifted?

Yes, they would. There are at least two companies today developing CBD products. Pharmaceutical companies will only invest when they can own intellectual property. They cannot afford to develop products if they cannot get a return on their investments. There are several more companies looking at developing these medications, provided the regulations allow them to get that return.

Are their ways to predict when regular or recreational use becomes addiction? And probably a sensitive question: what is your definition of problematic opiate use?

Addiction occurs when the use of an opioid is associated with craving and compulsive use despite harm. Problematic opioid use occurs when it's used for a non-medical or inappropriate purpose and when the potential risks exceed the potential benefits.

Do you believe someone can use opioids chronically under a doctor and not become psychologically dependent?

Yes, millions of people have used opioids without becoming psychologically dependent or becoming addicted.

I have additional question: How often do you run these trials and how do you ensure they're safe? Given that opiates are pretty addictive, this seems like a pretty big concern, recreational users or not.

One, we are conducting trials on a continual basis. Our trials are not just about opioids. We may study antidepressants, stimulants, benzodiazepines, cannabinoids, new chemical entities, etc...

And two, safety is our number one concern. We are very familiar with the doses that are administered and monitored continuously during a clinical trial. Furthermore, the FDA reviews all protocols to be sure they are safe for the subjects.

Hi Dr. Webster and kudos to you for trying to solve this epidemic while some other officials seem to be in denial. 1. Do you believe that Kratom can be used as a substitute for more addictive and deadly opioid painkillers? 2. Do you believe that the denial of the opioid epidemic, especially in colleges and schools, directly effects the overdose rate(whether positively or negatively? 3. How do you feel on the decriminalization of opioid painkillers in order to help addicts instead of hurting them. And as to your question I believe that providing safer alternatives to opioid painkillers or providing better treatment for addiction will help to ease the death rate in this crisis, this as well as providing EDUCATION (NOT D.A.R.E propaganda that never worked on us as kids at all) about the dangers of opioid use. Those are my questions and thanks!

1. I don't believe we have the research to state what Kratom can do. It does appear to have potential, but we need the research.

2. I'm not sure anyone's denying that there's an opioid crisis in America. We must recognize this is a serious problem and address it head-on.

3. I don't know what you mean by decriminalized. If you mean there won't be any regulation around opioids, I would be concerned that this would contribute harm to a subset of people in society. We should be able to provide treatments whether opioids or not under a regulatory environment.

Without divulging any obviously NDA-protected information, might i inquire what receptor pathways you're investigating to create the "perfect" painkiller? It's been 70 years of searching by the pharmaceutical industry, and the best opioid receptor-acting drugs seem to be the the classics and then investigational, functionally-selective agonists that don't trigger beta-arrestin recruitment (and even here, despite what seems to be a reduced propensity for tolerance, addiction, and overdose, it's not holy grail: never mind that it hasn't been studied in humans.)

Personally, I believe that different types of pain warrant different treatments, and there will always be a place for opioid drugs in acute, visceral pain. However, when it comes to chronic or neuropathic pain, the efficacy just doesn't seem to be there, and this is where I would be targeting research at what the exact mechanisms here are underpinning the difference in pain propagation and why MOR agonists are poor modulators of it.

In a nut shell, I guess, are you investigating further modulators of the opioid system, or are you looking at other neural systems (e.g. cannabinoid receptors, TOLL receptors)? Thanks for your time!

We're looking at all of the above receptors. You are precisely correct that the treatment of pain requires a multi-modal approach. There will not be one medication that is effective for all types of pain.

I think the way we will advance treating pain will be more personalized than the shotgun approach of using opioids of the past. I often use the analogy of cancer therapy. Chemotherapy targets many different sites to be effective. Pain therapy will need to target many different sites to also be effective. The future looks good, but it will take some time to get there.

I plan on taking Vivitrol when I leave my inpatient rehab 10/10. My nurse explained to me that you can still overdose while on Vivitrol while not getting high. How is that? Also, what physiological/ psychological roll does NA play in recovery?

Yes, you can still overdose on an opioid while taking Vivitrol. Vivitrol is now Naltrexone. Naltrexone and opioids compete for the receptor. If the receptor is flooded with large amounts of opioid, it can override the effect of Naltrexone.

NA can be very supportive if you are in the correct group. NA can be a community of support.

As a recovering addict of opiates, and a person who consistently has ankle/leg pain, what other treatments do you suggest? Everyday I struggle with pain (restless nights, pain at work, and sometimes my leg/ankle will go to "sleep") and OTC medication do not work, but I will not let myself fall back into addiction even with the "cravings" I have. Only when the pain is at its worst do I even consider taking an opiate, but I'm glad I haven't yet.
I do think Endo Pharmacy's formulation on the ER Oxymorphone is nearly 95% tamper proof, but the bioavailability of oxymorphone orally is not enough to subdue the pain. I think if they use that formula with Oxycodone it would be a more effective medicine and more tamper resistant.

There are many treatment options for you -- I cannot list them all here. Most are non-opioid. I recommend you find a physician who practices inter-disciplinary medicine. That person should be very helpful to you.

How does one try and sign up for this trial?

Please go here.